A clinical trial to compare the preventive effects of Atorvastatin and Rosuvasatin on kidney damage in patients undergoing cardiac surgery

A Comparative Study of High Dose Atorvastatin and Rosuvastatin in Prevention of Contrast Induced Nephropathy in Patients Undergoing Percutaneous Transluminal Coronary Angioplasty - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/08/056801

Enrollment

108

Registered

2023-08-23

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I700- Atherosclerosis of aorta

Interventions

Intervention1: ATORVASTATIN plus Intravenous Normal saline: ATORVASTATIN 80mg, Once a day for 3 days, orally administered plus Intravenous Normal saline for 12 hrs Intervention2: ROSUVASTATIN plus Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender aged between 18 and 70 years 2. Patients on stable dose of statins 3. Patients posted for PTCA requiring = 100ml contrast

Exclusion criteria

Exclusion criteria: 1. Patients with high-risk features like cardiogenic shock, acute pulmonary edema and bleeding complications 2. ESRD requiring dialysis 3. Patients who have received intravenous contrast in the last 2 weeks 4. contraindications to statin treatment 5. patients on concomitant use of potential nephrotoxic agents 6. pregnancy and lactating women

Design outcomes

Primary

Measure	Time frame
1. Change in serum creatinine levels & eGFR after pre-treatment with Atorvastatin & Rosuvastatin. 2. Change in Cystatin-C levels after pre-treatment with Atorvastatin & Rosuvastatin.Timepoint: 1. Change in serum creatinine levels & eGFR in 48hrs after pre-treatment with Atorvastatin & Rosuvastatin. 2. Change in Cystatin-C levels in 24hrs after pre-treatment with Atorvastatin and Rosuvastatin.	—

Secondary

Measure	Time frame
1. Proportion of patients showing Adverse Drug Reactions to high dose Atorvastatin & Rosuvastatin. 2. Incidence of CIN after pre-treatment with Atorvastatin & Rosuvastatin.Timepoint: Incidence of CIN in 48hrs after pre-treatment with Atorvastatin and Rosuvastatin.	—

Countries

India

Contacts

Public ContactT S Ushasree

ESIC Medical College and Hospital

tummalasreddy@gmail.com9440933220

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026